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FDA 510(k)

Brainance MD

K-Number: K202808 · 2021-10-14

Decision Date2021-10-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brainance MD is a medical device manufactured by Advantis Medical Imaging Single Member P.C.. It received FDA 510(k) clearance on 2021-10-14 under approval number K202808. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainance MD?

Brainance MD is a medical device that received FDA 510(k) clearance on 2021-10-14. It is manufactured by Advantis Medical Imaging Single Member P.C.. The 510(k) number is K202808.

When was Brainance MD approved by the FDA?

Brainance MD received FDA 510(k) clearance on 2021-10-14, under approval number K202808.

What company makes Brainance MD?

Brainance MD is manufactured by Advantis Medical Imaging Single Member P.C..

What is the FDA product code for Brainance MD?

The FDA product code for Brainance MD is LLZ.

Other Devices by Advantis Medical Imaging Single Member P.C.

Related Devices (Code: LLZ)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.